DCGI Halts Entod Pharma's Eye Drops for Presbyopia Due to Unapproved Claims
DCGI Suspends Eye Drops by Entod Pharma
The DCGI has halted the authorization granted to Entod Pharmaceuticals, based in Mumbai, to manufacture and market its new eye drops. This suspension arose after the company made claims that their product could reduce reliance on reading glasses for individuals suffering from presbyopia.
Background on Presbyopia and Regulatory Concerns
As explained by the National Eye Institute, presbyopia is a condition that impairs the ability of middle-aged and older adults to see nearby objects clearly. The drug authority asserted that Entod violated the New Drugs and Clinical Trial Rules, 2019, claiming benefits without the necessary clearance from the Central Licensing Authority.
Entod Pharmaceuticals' Response
- The Drugs Controller General of India (DCGI) noted the company was granted initial approval for the production of Pilocarpine Hydrochloride Ophthalmic Solution on August 20.
- Following the claims made, the regulatory body requested an explanation on September 4, leading to a response from Entod.
- Nikkhil K. Masurkar, CEO of the company, has announced plans to contest this regulatory suspension in court.
As this issue evolves, further updates will follow on the implications for eye drops in India and the regulatory landscape surrounding them.
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